FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEN SHUENG ENTERPRISE CO.
K Number: K940625
·
Decision Jul 12, 1994
Classifications
1
FEI Numbers
1390
Registration Numbers
1390
Same Product Code
645
Applicant Total
6
Review Days
148
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Basic Information
- Device Name
- CHEN SHUENG ENTERPRISE CO.
- K Number
- K940625
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.5850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sunny Sunglasses
- Date Received
- February 14, 1994
- Decision Date
- July 12, 1994
- Product Code
- HQY
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
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Other Clearances by Sunny Sunglasses
| K Number | Device Name | ||
|---|---|---|---|
| K940626 | CLEVER OPTICAL INDUSTRIES LTD | Jul 12, 1994 | Substantially Equivalent |
| K940627 | WENZHOU IMPORT AND EXPORT CORP | Jul 12, 1994 | Substantially Equivalent |
| K940924 | SUNGLASSES | Jul 12, 1994 | Substantially Equivalent |
| K940628 | JIHN MEI OPTICAL CO. | Jul 12, 1994 | Substantially Equivalent |
| K940629 | YEOU NAN SUNGLASSES CO | Jul 12, 1994 | Substantially Equivalent |